NCT00121914

Brief Summary

Hepatocellular carcinoma (HCC) is a consequence of liver cirrhosis. In early tumour stages, tumour resection or liver transplantation are therapeutic options; later tumour stages may be treated with locally ablative treatments such as percutaneous ethanol instillation (PEI), transarterial chemoembolization (TACE) or radio-frequency thermoablation. This randomized study investigates the effect of PEI on survival of patients with HCC. All patients will receive hormonal treatment (long-acting somatostatin intramuscularly \[i.m.\]) and will be randomized for treatment with PEI or no additional treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
Last Updated

October 18, 2005

Status Verified

July 1, 2005

First QC Date

July 15, 2005

Last Update Submit

October 17, 2005

Conditions

Carcinoma, Hepatocellular

Keywords

Carcinoma, Hepatocellular,percutaneous ethanol instillationlong-acting somatostatin

Outcome Measures

Primary Outcomes (2)

  • survival time

  • time to tumour progression

Secondary Outcomes (2)

  • quality of life

  • causes of death

Interventions

percutaneous ethanol instillation (PEI)PROCEDURE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically-proven hepatocellular carcinoma
  • Treatable with percutaneous ethanol instillation
  • Inoperable tumour
  • Age 18-85 years

You may not qualify if:

  • Liver cirrhosis Child C
  • Tumour diameter \> 8 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaetsklinik fuer Innere Medizin IV / Gastroenterologie und Hepatologie

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • Muller C, Schoniger-Hekele M, Schernthaner R, Renner B, Peck-Radosavljevic M, Brichta A, Wrba F, Posch M, Bauer P, Ferenci P, Gangl A. Percutaneous ethanol instillation therapy for hepatocellular carcinoma - a randomized controlled trial. Wien Klin Wochenschr. 2008;120(19-20):608-18. doi: 10.1007/s00508-008-1086-2.

    PMID: 19083165DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Christian Mueller, MD

    Universitaetsklinik fuer Innere Medizin IV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2005

First Posted

July 21, 2005

Study Start

October 1, 2000

Study Completion

July 1, 2005

Last Updated

October 18, 2005

Record last verified: 2005-07

Locations

AU(1)